Cleared Traditional

K062096 - KOREAMEDICO CHEXTIC HCG URINE PREGNANCY TEST

K062096 is an FDA 510(k) clearance for KOREAMEDICO CHEXTIC HCG URINE PREGNANCY..., manufactured by Koreamedico Co. , Ltd.. The device is a Class 2 Chemistry device with product code LCX cleared through the Traditional 510(k) pathway after a 287-day FDA review.

K062096 · Koreamedico Co. , Ltd. · Chemistry device
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May 2007
Decision
287d
Days
Class 2
Risk

K062096 is an FDA 510(k) clearance for the KOREAMEDICO CHEXTIC HCG URINE PREGNANCY TEST. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Koreamedico Co. , Ltd. (Seoul, KR). The FDA issued a Cleared decision on May 7, 2007 after a review of 287 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1155 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Koreamedico Co. , Ltd. devices

FDA 510(k) Submission Details - K062096

510(k) Number K062096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2006
Decision Date May 07, 2007
Days to Decision 287 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
199d slower than avg
Panel avg: 88d · This submission: 287d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LCX Device Classification - Class 2, Special Controls

Product Code LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1155
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - LCX Kit, Test, Pregnancy, Hcg, Over The Counter

All 148
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K062096.
HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE)
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K070054 · Church & Dwight Co., Inc. · May 2007
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K060128 · Unipath , Ltd. · May 2006